Cleared Traditional

BTL-785MJ

K243290 · BTL Industries, Inc. · Dental

May 2025

Decision

203d

Days

Class 2

Risk

About This 510(k) Submission

K243290 is an FDA 510(k) clearance for the BTL-785MJ, a Stimulator, Muscle, Powered, Dental (Class II — Special Controls, product code NUW), submitted by BTL Industries, Inc. (Malborough, US). The FDA issued a Cleared decision on May 9, 2025, 203 days after receiving the submission on October 18, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K243290 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 18, 2024
Decision Date	May 09, 2025
Days to Decision	203 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NUW — Stimulator, Muscle, Powered, Dental
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 890.5850
Definition	Relief Of Muscle Spasms Associated With Tmj. Muscle Reeducation, Increasing Blood Flow.